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RSS FeedPosted by Michael Wonder on 13 Oct 2023
BeiGene receives positive CHMP opinion for Brukinsa (zanubrutinib) in relapsed or refractory follicular lymphoma
13 October 2023 - If approved, Brukinsa will be the first and only BTK inhibitor approved for follicular lymphoma. ...
Posted by Michael Wonder on 13 Oct 2023
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) plus chemotherapy as first-line treatment for HER2 negative advanced gastric or gastro-oesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)
13 October 2023 - Opinion granted based on positive overall survival results from the Phase 3 KEYNOTE-859 trial. ...
Posted by Michael Wonder on 13 Oct 2023
New treatment option for heavily pre-treated multiple myeloma patients
13 October 2023 - EMA’s CHMP has recommended a conditional marketing authorisation in the European Union for Elrexfio (elranatamab) as a ...
Posted by Michael Wonder on 13 Oct 2023
Astellas receives positive CHMP opinion for Veoza (fezolinetant)
13 October 2023 - Fezolinetant is an investigational non-hormonal treatment for vasomotor symptoms associated with menopause. ...
Posted by Michael Wonder on 13 Oct 2023
Vueway (gadopiclenol) receives positive CHMP opinion
12 October 2023 - The CHMP of the EMA recommended approval of the macrocyclic, high relaxivity Vueway (gadopiclenol) in adults ...
Posted by Michael Wonder on 11 Oct 2023
EMA publishes agenda for 9-12 October 2023 CHMP meeting
9 October 2023 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 11 Oct 2023
Cosmo announces submission of Winlevi to the EMA
10 October 2023 - Submission to EMA is supported and based on the efficacy and safety evidence gathered in two identical, ...
Posted by Michael Wonder on 07 Oct 2023
Janssen submits application to the European Medicines Agency for Rybrevant (amivantamab) in combination with chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer with activating EGFR exon 20 insertion mutations
6 October 2023 - Type II extension of indication application is supported by data from PAPILLON, the first randomised Phase 3 ...
Posted by Michael Wonder on 03 Oct 2023
Formycon and Fresenius Kabi announce EMA acceptance of the marketing authorisation application for FYB202, an ustekinumab biosimilar candidate
29 September 2023 - Formycon and its commercialisation partner Fresenius Kabi today announced that the EMA has accepted the marketing authorisation ...
Posted by Michael Wonder on 30 Sep 2023
Geron announces EMA validation of marketing authorisation application for imetelstat for the treatment of lower risk MDS
29 September 2023 - Geron Corporation today announced that the EMA has validated the marketing authorisation application for imetelstat, a first-in-class ...
Posted by Michael Wonder on 29 Sep 2023
STADA and Calliditas announce the filing for full marketing authorisation of Kinpeygo in the EU
28 September 2023 - Submission to the CHMP for full approval is based on the full two-year data set from the ...
Posted by Michael Wonder on 26 Sep 2023
Sandoz receives European Commission approval for Tyruko (natalizumab), first and only biosimilar for multiple sclerosis in Europe
26 September 2023 - Decision based on evidence from extensive analytical characterisation demonstrating similarity of biosimilar with reference biologic, in addition ...
Posted by Michael Wonder on 25 Sep 2023
AbbVie announces European Commission approval of Tepkinly (epcoritamab) for adults with relapsed or refractory diffuse large B-cell lymphoma
25 September 2023 - Conditional marketing authorisation approval from the European Commission is supported by data from the pivotal Phase 1/2 ...
Posted by Michael Wonder on 23 Sep 2023
Jazz Pharmaceuticals receives European Commission approval for Enrylaze (a recombinant Erwinia asparaginase or crisantaspase) for the treatment of acute lymphoblastic leukaemia and lymphoblastic lymphoma
21 September 2023 - Jazz Pharmaceuticals today announced that the European Commission has granted marketing authorisation for Enrylaze (JZP458; a recombinant ...
Posted by Michael Wonder on 23 Sep 2023
European Commission authorises ViiV Healthcare’s Apretude (cabotegravir long-acting and tablets) for HIV prevention
19 September 2023 - Given as few as six times per year, cabotegravir has demonstrated superior efficacy to a daily oral ...